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You are required to write a consent letter for your NCU IRB application if all of the following are true:
You plan to conduct human subjects research
You will be recruiting participants who are age 18+
Introduction to Consent
You will write a consent letter so that potential participants have all the information about your study in one place and can make an informed decision as to whether they want to participate in your study. A consent letter is just one part of the informed consent process. Informed consent is an ongoing process that begins during recruitment and continues throughout the study.
How do I collect consent?
If you are engaging with participants in real-time (interviews, focus groups, observations, etc.), you may send potential participants a copy of the consent letter before you meet with them. You then must do the following:
Set aside time to read through the consent letter with each participant. As you read through, remind participants that they do not have to participate if they do not want to, they can skip any question they do not want to answer, they can skip any activity they do not want to participate in, and they can stop participating at any time.
Give participants an opportunity to ask questions about your study.
Ask participants for verbal consent (e.g., "Do you still want to participate in this study?"). For Exempt and Expedited studies, the NCU IRB does not require you to collect participant signatures or any written documentation of consent (if you are using a site IRB, they may require participant signatures). For more information, watch the webinar below:
Do I need to reword the template to avoid plagiarism?
No! Using a required template is not plagiarism. The consent letter template has language that is required by federal regulations. You should not change or revise any of the template language.
How do I write my consent letter if I have multiple participant groups?
If you have multiple participant groups who are all doing the same activities and answering questions about the same topics, you will use 1 consent letter for all groups. You should add subheadings to the eligibility section to clearly label each group and list the criteria separately for each group. Review the Consent Letter Examples for assistance.
If any of your participant groups are doing different activities or answering questions about different topics, you will use a separate consent letter for each group.
Get feedback on your consent letter
The NCU IRB recommends that you receive feedback on your consent letter before you submit your IRB application: